Cleared Traditional

LITE-BLADE

K944428 · Eare Consulting Service · Anesthesiology
Nov 1994
Decision
64d
Days
Class 1
Risk

About This 510(k) Submission

K944428 is an FDA 510(k) clearance for the LITE-BLADE, a Laryngoscope, Rigid (Class I — General Controls, product code CCW), submitted by Eare Consulting Service (Eilat, IL). The FDA issued a Cleared decision on November 15, 1994, 64 days after receiving the submission on September 12, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5540.

Submission Details

510(k) Number K944428 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 1994
Decision Date November 15, 1994
Days to Decision 64 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CCW — Laryngoscope, Rigid
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5540

Similar Devices — CCW Laryngoscope, Rigid

All 63
APA Oxy Blade
K191602 · Venner Medical (Singapore) Pte, Ltd. · Aug 2019
Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)
K163412 · Girgis Scope, LLC · Jun 2017
YEESCOPE LARYNGOSCOPES
K140951 · Yeescope Pty. , Ltd. · Nov 2014
AIRTRAQ SP AIRTRAQ AVANT
K121378 · Prodol Meditec , Ltd. · Jun 2012
NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET
K063477 · Novamed, LLC · Feb 2007
TRU-MR LARYNGOSCOPE SET
K062523 · Truphatek International, Ltd. · Nov 2006